MRE Consumption and Gut Health

• ClinicalTrials.gov Identifier: NCT02423551
• Recruitment Status: Completed
• First Posted: April 22, 2015
• Last Update Posted: April 16, 2019
• Sponsor: United States Army Research Institute of Environmental Medicine
• Information provided by (Responsible Party): James Philip Karl, United States Army Research Institute of Environmental Medicine

Study Description

Brief Summary:

The objective of this study is to determine the impact of consuming MREs as the sole source of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80 free-living adults will be randomized to consume their usual diet or only MREs for 21 consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be collected periodically before, during and after the intervention to measure gut barrier integrity, gut bacteria community composition, and markers of gut health, inflammation, and nutritional status.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Tract	Other: MRE	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health
• Actual Study Start Date: April 2015
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Usual diet
Experimental: MRE; MRE consumption	Other: MRE; MRE consumption

Outcome Measures

Primary Outcome Measures :

1. Change in gut barrier integrity [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations

Secondary Outcome Measures :

1. Change in gut microbiota composition [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   16S rRNA gene sequencing
2. Change in C-reactive protein concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Serum C-reactive protein
3. Change in TNF-alpha concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Serum TNF-alpha
4. Change in interleukin-6 concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Serum IL-6
5. Change in lipopolysaccharide concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Plasma LPS
6. Change in iron status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit
7. Change in vitamin D status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone
8. Change in B-vitamin status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Blood folate, vitamin B12, homocysteine
9. Change in nutritional status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
   Blood prealbumin
10. Change in calcium absorption [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Urine calcium
11. Change in zinc status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Blood zinc, zinc receptor expression

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 62 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• BMI </= 30

Exclusion Criteria:

• Use of antiobiotcs within 3 months of study participation
• Use of pro- or prebiotic supplements within 2 weeks of study participation
• Vegetarian diets
• Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.
• Fewer than 4 bowel movements, on average, per week
• History of gastrointestinal disease
• Colonoscopy within 3 months of study participation
• Food allergies or aversions or other issues with foods that would preclude MRE consumption, including gluten, milk, nuts, or eggs.
• Use non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or unwillingness to discontinue the use of these substances during the study.
• Actively trying to lose weight
• Pregnant or lactating
• Recent blood donation

Contacts and Locations

Locations

United States, Massachusetts

USARIEM

Natick, Massachusetts, United States, 01760

Sponsors and Collaborators

United States Army Research Institute of Environmental Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karl JP, Armstrong NJ, Player RA, Rood JC, Soares JW, McClung HL. The fecal metabolome links diet composition, food processing and the gut microbiota to gastrointestinal health in a randomized trial of adults consuming a processed diet. J Nutr. 2022 Jul 26:nxac161. doi: 10.1093/jn/nxac161. Online ahead of print.

McClung HL, Armstrong NJ, Hennigar SR, Staab JS, Montain SJ, Karl JP. Randomized Trial Comparing Consumption of Military Rations to Usual Intake for 21 Consecutive Days: Nutrient Adequacy and Indicators of Health Status. J Acad Nutr Diet. 2020 Nov;120(11):1791-1804. doi: 10.1016/j.jand.2020.06.018. Epub 2020 Aug 19.

• Responsible Party: James Philip Karl, Research Dietitian, United States Army Research Institute of Environmental Medicine
• ClinicalTrials.gov Identifier: NCT02423551
• Other Study ID Numbers: 15-12HC
• First Posted: April 22, 2015
• Last Update Posted: April 16, 2019
• Last Verified: April 2019

Keywords provided by James Philip Karl, United States Army Research Institute of Environmental Medicine:

Gut microbiota; Intestinal permeability; Gut barrier integrity